Quality Engineer

Nextern is a manufacturing company operating in highly regulated industries with a focus on quality and compliance.
Backend
Senior Software Engineer
In-Person
5+ years of experience
Healthcare

Description For Quality Engineer

Nextern is seeking a Quality Engineer to tactically manage quality requirements between the company and key customers. This role ensures customer quality expectations and daily requirements in engineering, production development, and supply chain are met. The position focuses on balancing responsibilities across areas to achieve product quality performance while maintaining compliance with company requirements, regulatory agencies, and customer guidelines. The ideal candidate will have strong experience in quality management systems, leading investigations, and product development support. This role offers an opportunity to work in a regulated manufacturing environment where you can make a significant impact on product quality and process improvement.

Last updated 14 days ago

Responsibilities For Quality Engineer

  • Lead complaint and CAPA investigations
  • Experience in product labelling implementation and control
  • Communicate with external and internal clients directly
  • Perform internal audits
  • Lead changes to QMS documents
  • Lead validations, TMVs
  • Execute IIR and FAIR reports with no support
  • Provide support to engineering activities from other areas, such as IQs, OQs, PQs
  • Performs new product introduction activities
  • Support quality activities for product development and transfer
  • Provide mentoring in Investigations and Root Cause Analysis tools
  • Provide support to other engineering areas
  • Participate as Quality leader in development projects

Requirements For Quality Engineer

  • Bachelor's degree in engineering or a life sciences-related major, desirable a postgraduate degree in related areas
  • 5 years of engineering/quality experience in a highly regulated manufacturing/industry environment
  • English level C1, B2
  • Must demonstrate value adding competencies at establishing collaborative relations, operational excellence and agile decision making
  • Show high competency level in people development

Benefits For Quality Engineer

  • Competitive compensation package
  • Optimal working environment

Interested in this job?

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